Senior QC Analyst, Stability

Global Quality Bothell, Washington


Description

Summary:

The Quality Control at Seagen is seeking an experienced professional with knowledge and experience in coordinating and managing stability program setups, monitoring stability data, evaluating results/trends, maintaining stability protocols and reports in support of commercial and clinical stability studies.

Key Responsibilities:

  • Generate stability documentation including stability protocols, stability reports, data for regulatory submissions and annual Product Quality Report stability sections
  • Support QC Lead designing product stability protocols aligned with program strategy and current regulatory requirements
  • Oversee stability study initiation, review stability template in LIMS, track time points for testing, and ensure stability studies are executed according to protocol
  • Stability data review and data management for assigned programs
  • Evaluate stability results to support expiry, trending, and conditions for real-world use
  • Prepare stability reports, product expiry dating and shelf-life documents summarizing stability data as requested for internal or regulatory filing
  • Escalate unexpected data trends, OOS events, and risks appropriately, and drives/supports resolution
  • Provide support in regulatory inspection, audits for stability business processes, including implementation of corrective actions
     

Required Qualifications:

  • BS in life sciences or related Life Sciences discipline
  • 8+ years working experience in pharmaceutical or biotech field, some laboratory experience in QC or development is preferred
  • Familiarity with pharmaceutical and biological product stability study requirements
  • Must have a thorough knowledge and understanding of cGMP and regulatory requirements/guidance for stability programs
  • Must be able to manage multiple high priority projects and multiple tasks while maintaining direction and adherence to timelines
  • Good communication in presentation and written form to staff at all organizational levels
  • Experience in authoring stability protocol/report, stability related SOP, and documents
  • Experience working on a cross-functional team in a matrix environment

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. 

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